FDA approves Samsung Bioepis' copy of J&J's Remicade: company

Reuters

21 April 2017 - South Korea's Samsung Bioepis said on Saturday the U.S. FDA approved its copy of Johnson & Johnson's rheumatoid arthritis drug Remicade, the first drug developed by the Samsung Group unit approved in the United States.

The drug, called Renflexis, is a biosimilar – a copy of a biotech drug - and the second Remicade copy to be approved in the world's largest pharmaceutical market. Remicade is J&J's biggest selling drug with U.S. sales of about $5 billion a year.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Biosimilar